{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"User Fees and Refunds for Premarket Notification Submissions (510(k)s).\" This guidance describes the user fees and refunds associated with the 510(k) program. The guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2004/05/28/04-12103.html","cfr_references":[],"citation":"69 FR 30672","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on this guidance at any time.","disposition_notes":null,"docket_ids":["Docket No. 2003D-0537"],"dockets":[],"document_number":"04-12103","effective_on":null,"end_page":30673,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/05/28/04-12103.xml","html_url":"https://www.federalregister.gov/documents/2004/05/28/04-12103/guidance-for-industry-and-fda-staff-user-fees-and-refunds-for-premarket-notification-submissions","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-12103?publication_date=2004-05-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-05-28/04-12103/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":48,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-05-28/pdf/04-12103.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-05-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/05/28/04-12103.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T12:29:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":30672,"subtype":null,"title":"Guidance for Industry and FDA Staff; User Fees and Refunds for Premarket Notification Submissions; Availability","toc_doc":"Premarket notification submissions; user fees and refunds","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":69}